NCT02080871已完成不适用
Evaluation of the Gore(R) Viabahn(R) Balloon Expandable Endoprosthesis (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries.
W.L.Gore & Associates53 个研究点 分布在 2 个国家目标入组 134 人开始时间: 2014年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 53
- 主要终点
- Composite of Major Adverse Events (MAEs)
研究概览
简要总结
Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.
详细描述
This study is a prospective, multicenter, non-randomized single-arm clinical study to evaluate the safety and efficacy of the VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years old;
- •Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
- •Patient or legal representative is willing to give written informed consent;
- •Patient is capable of complying with protocol requirements, including all follow-up visits;
- •Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
- •Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery;
- •Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate;
- •Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm;
- •Patient has adequate ipsilateral blood flow including at least one sufficient (<50% stenotic) infrapopliteal run-off vessel not requiring intervention (per side to be intervened on).
- •Patient has a total target lesion length visually estimated to be ≤110 mm which can be treated with a maximum of three VIABAHN BX endoprostheses;
- •Patient has no more than two discrete ipsilateral lesions that can be treated with no more than three VIABAHN BX endoprostheses [OR] Patient has bilateral disease consisting of only one target lesion per side that can be treated with no more than a total of three VIABAHN BX endoprostheses;
- •Patient has the device advanced across the target lesion(s) and positioned for deployment.
排除标准
- •Patient has a life expectancy of less than 1 year;
- •Patient has a known allergy to stent graft components, including stainless steel or heparin;
- •Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
- •Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
- •Patient has an uncorrected bleeding disorder (platelet count < 80,000/µL);
- •Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not on hemodialysis;
- •Patient has a known hypercoagulability that cannot be corrected;
- •Patient has evidence of a blood borne infection;
- •Patient has had vascular access/catheterization in the lower extremity within 30 days of study enrollment;
- •Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure;
- •Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the index procedure;
- •Patient is currently participating in this or another investigative clinical study.
- •Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s);
- •Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
- •Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
- •Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
- •Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent.
研究组 & 干预措施
Gore VIABAHN BX
Experimental
Balloon expandable stenting of iliac occlusive disease
干预措施: Stenting of the Common and/or External Iliac Arteries (Device)
结局指标
主要结局
Composite of Major Adverse Events (MAEs)
时间窗: 9 months
Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death within 30 days, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.
次要结局
- 30-Day Clinical Success(30 Days)
- Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)(36 Months)
- Percentage of Participants With Primary Patency(12 Months)
- Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)(36 Months)
- Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)(36 Months)
- Acute Procedural Success(Discharge)
- Percentage of Participants With Primary Assisted Patency(12 Months)
- Percentage of Participants With Secondary Patency(12 Months)
- Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)(36 Months)
- Number of Participants With Change in Rutherford Category(36 Months)
- Change in Ankle Brachial Index (ABI)(36 Months)
- Number of Participants With Change in Functional Status - EQ5D - Mobility(36 Months)
- Number of Participants With Change in Functional Status - EQ5D - Self Care(36 Months)
- Number of Participants With Change in Functional Status - EQ5D - Usual Activities(36 Months)
- Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort(36 Months)
- Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression(36 Months)
- Number of Participants With Change in Functional Status - EQ5D - Own Health State(36 Months)
- Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)(30 Days)
- Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)(9 Months)
研究者
研究点 (53)
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